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Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01284478
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
Allergan
Information provided by:
Northern California Retina Vitreous Associates

Brief Summary:
The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

Condition or disease Intervention/treatment Phase
Pseudophakic Cystoid Macular Edema, Diabetic Macular Edema Drug: Dexamethasone Implant Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

Arm Intervention/treatment
Dexamethasone Implant
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Drug: Dexamethasone Implant
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally



Primary Outcome Measures :
  1. BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 180 ]

Secondary Outcome Measures :
  1. RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 and 180 DAYS ]
    CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
  • VISUAL ACUITY WORSE THAN 20/32

Exclusion Criteria:

  • VISUAL ACUITY WORSE THAN 20/200
  • MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
  • USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284478


Locations
United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Sponsors and Collaborators
Northern California Retina Vitreous Associates
Allergan
Investigators
Principal Investigator: Rahul Khurana, MD Northern California Retina Vitreous Associates

Responsible Party: RAHUL KHURANA, M.D. / PRINCIPAL INVESTIGATOR, NORTHERN CALIFORNIA RETINA VITREOUS ASSOCIATES
ClinicalTrials.gov Identifier: NCT01284478     History of Changes
Other Study ID Numbers: NCRVA-2011-Ozurdex-16-1
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Northern California Retina Vitreous Associates:
pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone

Additional relevant MeSH terms:
Edema
Cataract
Macular Edema
Capsule Opacification
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action